,i #aafth ,,congress #b;d ,session ,h4 ,r4 #fffj ,,in ,,the ,,house ,,of ,,representatives ,may #a1 #bjbj,ms4 ,blunt ,rochester 7for herself and ,mr4 ,carter of ,georgia7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to require the holders of approved applications for drugs to conduct a risk assessment to identify and evaluate risks to their supply chain and develop1 maintain1 and implement risk mitigation plans to address such risks1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,limit ,ongoing ,shortages and ,stabilize ,supply ,act of #bjbj or the ,,loss ,act of #bjbj4 #b4 ,risk assessments and risk mitigation plans for drugs 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejf;,c-#a of such ,act 7#ba ,u4,s4,c4 #cef;c-#a7 the following new section3 #ejf;,c-#b4 ,risk assessments and risk mitigation plans for drugs 7a7 ,covered drug defined ,in this section1 the term covered drug-- 7#a7 means a drug that-- 7,a7 is described in section #ejf;,c7a72 or 7,b7 is included1 or was included at any point during the preceding #e years1 in the drug shortage list in effect under section #ejf;,e2 and 7#b7 includes any such drug that is not required to be approved pursuant to an application under subsection 7b7 or 7j7 of section #eje of this ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act to be lawfully marketed4 7b7 ,requirement ,the manufacturer of a covered drug shall-- 7#a7 conduct a risk assessment that identifies and evaluates risks to the supply of the drug1 including vulnerabilities that would likely lead to a meaningful disruption in the supply of the drug in the ,united ,states2 7#b7 develop and maintain a risk mitigation plan to ensure the supply of the drug during such a shortage2 and 7#c7 implement such plan during such a shortage4 7c7 ,confidentiality ,the ,secretary shall-- 7#a7 maintain the confidentiality of any risk assessment1 and any risk mitigation plan1 under this section2 and 7#b7 limit the use by the ,secretary of information in such an assessment or plan to preventing1 mitigating1 or responding to a drug shortage4 7d7 ,guidance ,the ,secretary shall publish guidance on-- 7#a7 how manufacturers should work with their supply chain partners in developing the required risk assessments and risk mitigation plans2 7#b7 the elements of a risk mitigation plan under this section2 and 7#c7 the form and manner of developing and maintaining such plan4 7e7 ,inspection ,a risk mitigation plan under this section shall be subject to inspection and copying by the ,secretary under section #gjd4 7f7 ,expedited inspections and reviews ,the ,secretary may conduct an expedited inspection or review as described in section #ejf;,c7g7 for the purpose of facilitating the implementation of a risk management plan developed pursuant to this section4 4 7b7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7fff7 ,the failure to conduct a risk assessment1 or to develop1 maintain1 and implement a risk mitigation plan1 in accordance with section #ejf;,c-#b4 4 7c7 ,applicability ,the amendments made by this section apply beginning on the date that is #bd months after the date of enactment of this ,act1 except that the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall have discretion to allow persons subject to such amendments additional time to comply with such amendments as the ,secretary determines necessary4 #c4 ,discontinuance or interruption in production 7a7 ,active pharmaceutical ingredients 7#a7 ,active pharmaceutical ingredients ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended by adding at the end the following3 7j7 ,applicability with respect to active pharmaceutical ingredients ,this section shall apply with respect to an active pharmaceutical ingredient in a drug described in subsection 7a7 in the same manner and to the same extent as this section applies with respect to a drug described in subsection 7a71 except that subsection 7i7 shall not apply with respect to active pharmaceutical ingredients4 4 7#b7 ,guidance 7,a7 ,issuance ,not later than #bd months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue final guidance on implementing the amendment made by paragraph 7#a74 7,b7 ,contents ,the guidance required by subparagraph 7,a7 shall specify-- 7i7 the form and manner of the disclosures required by the amendment made by paragraph 7#a72 and 7ii7 the details that need to be included in such disclosures4 7b7 ,prohibited acts with respect to drugs and active pharmaceutical ingredients ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #b7;b71 is further amended by adding at the end the following3 7ggg7 ,the failure of a manufacturer of a drug described in section #ejf;,c7a7 or an active pharmaceutical ingredient of such a drug1 without a reasonable basis as determined by the ,secretary1 to notify the ,secretary of a permanent discontinuance or an interruption1 and the reasons for such discontinuance or interruption1 as required by section #ejf;,c4 4 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 apply beginning on the date that is #ahj days after the date of enactment of this ,act4